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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, femoral component, cemented, metal
Product CodeJDG
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 328 328
2018 451 451
2019 335 335
2020 1046 1046
2021 1206 1206
2022 886 886
2023 289 289
2024 87 87

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1718 1718
Fracture 535 535
Insufficient Information 439 439
Adverse Event Without Identified Device or Use Problem 370 370
Material Twisted/Bent 211 211
Crack 191 191
Material Deformation 166 166
Device Dislodged or Dislocated 139 139
Naturally Worn 136 136
Connection Problem 98 98
Defective Device 73 73
Material Fragmentation 65 65
Appropriate Term/Code Not Available 63 63
Detachment of Device or Device Component 62 62
Corroded 58 58
Loose or Intermittent Connection 53 53
Mechanical Problem 50 50
Unstable 43 43
Incomplete or Inadequate Connection 41 41
Dull, Blunt 38 38
Biocompatibility 37 37
Mechanics Altered 37 37
Mechanical Jam 30 30
Degraded 28 28
Migration or Expulsion of Device 26 26
Flaked 26 26
Material Erosion 24 24
Loosening of Implant Not Related to Bone-Ingrowth 24 24
Loss of Osseointegration 23 23
Material Separation 18 18
Migration 18 18
Physical Resistance/Sticking 18 18
Scratched Material 17 17
Peeled/Delaminated 16 16
Noise, Audible 16 16
Material Disintegration 15 15
Component Missing 15 15
Loss of or Failure to Bond 14 14
Malposition of Device 11 11
Metal Shedding Debris 10 10
Inadequacy of Device Shape and/or Size 9 9
Deformation Due to Compressive Stress 8 8
Activation, Positioning or Separation Problem 8 8
Premature Separation 8 8
Failure to Align 7 7
Nonstandard Device 7 7
Solder Joint Fracture 6 6
Difficult or Delayed Separation 6 6
Separation Failure 5 5
Positioning Problem 5 5
Material Integrity Problem 5 5
Positioning Failure 5 5
Failure To Adhere Or Bond 4 4
Difficult to Insert 4 4
Off-Label Use 4 4
Osseointegration Problem 4 4
Misconnection 4 4
Fitting Problem 4 4
Device Damaged Prior to Use 4 4
Defective Component 4 4
Sharp Edges 4 4
Patient Device Interaction Problem 4 4
Material Split, Cut or Torn 4 4
No Apparent Adverse Event 4 4
Unintended Movement 3 3
Device Handling Problem 3 3
Failure to Clean Adequately 3 3
Improper or Incorrect Procedure or Method 3 3
Difficult to Remove 3 3
Problem with Sterilization 3 3
Use of Device Problem 3 3
Failure to Osseointegrate 2 2
Device Appears to Trigger Rejection 2 2
Delivered as Unsterile Product 2 2
Incomplete Coaptation 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Damaged by Another Device 2 2
Difficult to Open or Close 2 2
Unclear Information 2 2
Device Fell 2 2
Activation Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Reset 1 1
Unraveled Material 1 1
Device Slipped 1 1
Component Incompatible 1 1
Contamination 1 1
Disconnection 1 1
Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2509 2509
No Known Impact Or Consequence To Patient 374 374
Pain 304 304
No Patient Involvement 238 238
No Consequences Or Impact To Patient 216 216
Injury 216 216
No Information 205 205
No Code Available 194 194
Joint Dislocation 161 161
Unspecified Infection 145 145
Failure of Implant 97 97
Inflammation 76 76
Reaction 68 68
Bone Fracture(s) 66 66
Tissue Damage 66 66
Test Result 64 64
Not Applicable 61 61
Insufficient Information 59 59
Osteolysis 53 53
Inadequate Osseointegration 43 43
Discomfort 43 43
Foreign Body Reaction 38 38
Metal Related Pathology 36 36
Limited Mobility Of The Implanted Joint 29 29
Foreign Body In Patient 27 27
Loss of Range of Motion 23 23
Ambulation Difficulties 18 18
Deformity/ Disfigurement 16 16
Fall 15 15
Swelling 14 14
Host-Tissue Reaction 13 13
Bacterial Infection 11 11
Hip Fracture 10 10
Thrombosis/Thrombus 10 10
Blood Loss 9 9
Death 9 9
Hypersensitivity/Allergic reaction 9 9
Impaired Healing 8 8
Device Embedded In Tissue or Plaque 7 7
Distress 7 7
Local Reaction 7 7
Nerve Damage 7 7
Thrombosis 6 6
Necrosis 6 6
Post Operative Wound Infection 6 6
Subluxation 6 6
Non-union Bone Fracture 5 5
Depression 5 5
Joint Swelling 5 5
Hematoma 5 5
Fatigue 5 5
Wound Dehiscence 5 5
Ossification 5 5
Weakness 4 4
Synovitis 4 4
Scar Tissue 4 4
Perforation 4 4
Confusion/ Disorientation 4 4
Swelling/ Edema 4 4
Joint Laxity 3 3
Malunion of Bone 3 3
Unspecified Tissue Injury 3 3
Muscle/Tendon Damage 3 3
Joint Disorder 3 3
Fluid Discharge 3 3
Toxicity 3 3
Peroneal Nerve Palsy 3 3
Scarring 3 3
Edema 3 3
Cyst(s) 3 3
Muscular Rigidity 3 3
Muscle Weakness 2 2
Nausea 2 2
Hemorrhage/Bleeding 2 2
Cellulitis 2 2
Infarction, Cerebral 2 2
Pulmonary Embolism 2 2
Arthritis 2 2
Dizziness 2 2
Urinary Tract Infection 2 2
Osteopenia/ Osteoporosis 2 2
Patient Problem/Medical Problem 2 2
Unequal Limb Length 2 2
Balance Problems 2 2
Implant Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Movement Disorder 1 1
Limb Fracture 1 1
Unspecified Musculoskeletal problem 1 1
Solid Tumour 1 1
Full thickness (Third Degree) Burn 1 1
Fibrosis 1 1
Cancer 1 1
Tissue Breakdown 1 1
Ventilator Dependent 1 1
Disability 1 1
Numbness 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Feb-17-2022
2 Howmedica Osteonics Corp. II Nov-30-2021
3 Waldemar Link GmbH & Co. KG (Mfg Site) II Mar-14-2024
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